The Medical Futurist

MAY 18, 2025

Clinical use is already accepted, new FDA approvals and new trials are underway targeting new niches, like pediatric surgeries. They have started a large-scale clinical trial involving 10,000 patients, expected to last two years, with plans to obtain CE marking by the end of 2024. Since then, the concept has become a reality.

Healthcare 64

Healthcare Hospital Medical Patient-Centered 64

FDA Law Blog

OCTOBER 12, 2022

Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA). It may not be clear to supply chain stakeholders which entities may be considered “harm reduction programs” for the purposes of this Guidance.

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Current shortages have been largely caused by supply chain issues and the recent recall of several baby formula products over concerns about contamination. They may have samples in stock, connections to other local organizations, or ideas of other places to call, such as your local WIC clinic.

Supply Chain 52

Supply Chain Specialization IT Family Medicine 52

FDA Law Blog

MARCH 1, 2023

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

Clinic 64

Clinic Supply Chain Clinical Practice Patient-Centered 64

FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. Section I.C

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

FDA Law Blog

SEPTEMBER 13, 2021

To counter this increase, the Administration threw its support behind proposals to levy an excise tax or a rebate for manufacturers that raise product prices faster than the rate of inflation with no clinical reason. Increase Transparency and Strengthen Supply Chain and Research Capacity. ADMINISTRATIVE ACTIONS.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98